14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
FDA 510(k)
FDA Class 2
·Radiology
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70606361·Sprint II Bracket Roth .018" 20 Brackets
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
STRYKER TRAUMA PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·March 23, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·July 14, 2022
CADD
FDA Adverse Event
Malfunction
·NULL·Product code FPA·August 17, 2021
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·June 6, 2022
OLYMPUS ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 26, 2013
AXIUM HELIX DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·June 13, 2008
9/10 COCR HEAD 28MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 6, 2011
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000960;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012